SecProbe.io

January 14, 2025
Patrick NJ Schnegelsberg
Chief Executive Officer
Picard Medical, Inc.
4 Palo Alto Square, Suite 200
Palo Alto, CA 94025
Re:Picard Medical, Inc.
Amendment No. 2 to Draft Registration Statement on Form S-1
Submitted December 26, 2024
CIK No. 0002030617
Dear Patrick NJ Schnegelsberg:
            We have reviewed your amended draft registration statement and have the following
comments.
            Please respond to this letter by providing the requested information and either
submitting an amended draft registration statement or publicly filing your registration
statement on EDGAR. If you do not believe a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
            After reviewing the information you provide in response to this letter and your
amended draft registration statement or filed registration statement, we may have additional
comments. Unless we note otherwise, any references to prior comments are to comments in
our December 10, 2024 letter.
Amendment No. 2 to Draft Registration Statement on Form S-1
Prospectus Summary
Our Business, page 1
1.We note your revised disclosure in response to comment 2. Please further revise your
disclosure to clarify, at first instance, the difference between a Bridge to
Transplantation ("BTT") and Bridge to Candidacy ("BTC") product.
We note your revised disclosure in response to comment 5, including that "[t]o our
knowledge, there is limited clinical data available to support [the dual LVAD's] safety
and efficacy because it has never been part of an FDA-approved clinical trial." Given
that statements regarding safety and efficacy are within the purview of the FDA or a 2.

January 14, 2025
Page 2
similar regulatory body, please remove this disclosure from your filing. As a related
matter, please provide support for your disclosures about the costs of dual LVADs,
including your disclosures about reimbursement. Also, tell us whether implantation of
a single LVAD is a procedure that competes with your current or future products and
if so, revise your disclosure accordingly, including the related costs and
reimbursement.
History of SynCardia and SynCardia TAH Development, page 2
3.We note your revised disclosure in response to comment 7, including that since June
2022, you have been "building up resources to address existing deficiencies and to
update all documentation to align with MDR requirements and [you] are planning to
reapply for an MDR CE mark during 2Q25." Please further revise your disclosure to
specify how you intend to address the deficiencies that led to the suspension of your
CE mark in December 2021. Please also clarify whether, since 2021, the Company
has notified their EU customers of the disclosed issues and suspension.
Clinical Efficacy, page 7
4.We note your revised disclosure that "[o]ne-year survival rates among patients who
received the SynCardia TAH in RWD settings range from between 75% and 86.6%,
depending on the experience of the center performing the procedures and on patient
profiles." Please revise your disclosure to describe how the experience of the centers
and patient profiles impacted survival rates, providing specifics about the experience
levels of the relevant centers and profiles of the relevant patients. As a related matter,
we note your disclosure that you "have over 30 active certified centers and
approximately twenty-one active centers that have completed at least one implant
during the 24 months preceding the date of this prospectus." Please revise your
disclosure to discuss the criteria for certification of these centers and the difference
between "active certified centers" and "active centers."
New Product Development, page 8
5.We note your revised disclosure that "Unicorn" prototype iterations have been "shown
to work utilizing [y]our standard bench test techniques," and "[f]uture iterations of this
design may be small and light enough to be implanted." Please revise your disclosure
to clarify next steps in achieving regulatory approval of Unicorn, your intended
timeline, and that regulatory approval of this and the other new products discussed in
this section is not guaranteed. In addition, please clarify what is meant by "shown to
work" in this context.
6.Your revised disclosure indicates that Emperor has "been shown to achieve pulsatile
flow with rates of cardiac output that match [y]our on-market SynCardia TAH."
Given your disclosure that you expect to perform first-in-animal trials of this system
in the first half of 2025, please clarify the trial, study, or test of the Emperor that has
"shown" cardiac output matching your on-market product, and clarify what is meant
by "match" in this context.

January 14, 2025
Page 3
Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations, page 64
7.Please refer to our prior comment 11. As previously requested, for each period
presented, explain the underlying reasons for the increase/decrease in revenues related
to sales in the U.S. market.
8.Please refer to our prior comments 12 and 13. As previously requested, for all periods
presented, revise to discuss cost of revenues as a percentage of sales and quantify the
significant components that led to the change, including the amount of inventory
charges in each period.
9.Please refer to our prior comment 14 and address the following comments:

•Tell us where you provide expanded disclosure that provides more detail for your
research and development expenses for each period presented, including but not
limited to by product candidate as well as by the nature of the expenses. To the
extent that you do not track expenses by product candidate, please disclose as
such.

•Explain what you mean by your new disclosure that "While research and
development supply expense are isolated by product, personnel are not."
Industry Overview, page 83
10.We note your revised disclosure in response to comment 22, including that your total
addressable market for total artificial hearts in the United States exceeds 15,000
patients, or approximately $2.6 billion, and that your serviceable addressable market
is approximately $200 million for the BTT label and $500 million for the BTC and
long-term indications, based on approximately 2,800 patients. Please revise to provide
the underlying data supporting your total addressable market and serviceable
addressable market calculations, including the data from your market research,
physician interviews, and disclosed sources supporting your patient estimates, and
how you arrived at market valuations using these patient estimates. In your discussion,
please clarify how you estimated the market for the BTC and long-term indications,
given that you have yet to receive regulatory approval to commercialize your product
for these indications.
Enforcement of Civil Liabilities, page 101
11.We note your revised disclosure in response to comment 26, including that you
conduct certain operations through subsidiaries located outside of the United States
and one of your directors resides outside the United States, and that it could be
difficult or impossible for investors to effect service of process on you or this
individual. Please further revise your disclosure to identify and discuss the difficulties
presented by the relevant rules and regulations in the specific countries in which your
subsidiaries operate and the country of residence of your director.

January 14, 2025
Page 4
Audited Financial Statements
Note 7. Commitments and Contingencies
(c) China Corporation, page F-19
12.Please refer to our prior comment 29 and address the following comments:

•Please clarify what you mean by SynCardia Beijing's "present form" and explain
the nature of their current operations.

•With reference to the guidance in both Rule 11-01(d) and ASC 805-10-55-3A-
55-9, please provide a more detailed analysis to support your belief that
SynCardia Beijing is not a business.
Note 9. Temporary Equity and Stockholder's Deficit
(a) Redeemable Convertible Preferred Stock, page F-20
13.Please refer to our prior comment 30. Revise your disclosure to more fully explain the
transactions regarding the December 2022 share issuance, similar to your response.
Exhibits
14.Please refile Exhibit 10.41 in the proper text-searchable format. Refer to Item
601(b)(10)(iv) of Regulation S-K and Item 301 of Regulation S-T.
            Please contact Julie Sherman at 202-551-3640 or Jeanne Baker at 202-551-3691 if
you have questions regarding comments on the financial statements and related
matters. Please contact Katherine Bagley at 202-551-2545 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:Michael J. Blankenship